Received Jun 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8661AA | IM / LA |
shaking and nearly fainting after vaccine administratio; pale; shaking and nearly fainting after vaccine administration; Dilated pupils; nauseous; Initial information received on 21-May-2026 regarding an unsolicited valid serious case received from other or unknown healthcare professional. This case involves a 17-year-old female patient who experienced shaking and nearly fainting after vaccine administration, pale, dilated pupils and nauseous after receiving meningococcal vaccine (MENQUADFI). The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 20-May-2026, the patient received meningococcal vaccine solution for injection (strength: standard) Dose 0.5 ml 1x(once) intramuscularly in left deltoid Lot Number: U8661AA, Expiration Date 28-Feb-2029 for immunization. On 20-May-2026, the patient was Pale (pallor), nauseous (nausea) (latency 2mins after vaccination) and om same day also experienced shaking and nearly fainting after vaccine administration (Tremor) (Syncope) and Dilated pupils (Mydriasis). Action taken: Not applicable. Corrective treatment: Not reported. Event outcome: Unknown for all Seriousness criteria: Medically significant for syncope.; Sender's Comments: Sanofi Company Comment dated 02-JUN-2026: This case involves a 17-year-old female patient who experienced shaking and nearly fainting after vaccine administration, pale, dilated pupils and nauseous after receiving meningococcal vaccine (MENQUADFI). Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
Comments: NONE